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Ontario coverage, price, criteria word for word, Health Canada status and shortages for one product

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CALCITRIOL

All injection strengths: not a benefit

Other products in the same Health Canada class (A11CC) — coverage varies; not interchangeable

  • Alfacalcidol (One-Alpha): general benefit

Calcitriol Injection USP · DIN 02399334 · 1mcg/mL · injection solution Amp-1mL Pk

Off-Formulary Interchangeable, not an ODB benefitDormant since 2025-04-23 · checked 2026-09-02 · What does dormant mean?
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria
Exceptional Access criteria on record are for Brand(s): Sterimax Calcitriol Injection; DOSAGE FORM/ STRENGTH: 1 mcg/mL — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Calcitriol Brand(s): Sterimax Calcitriol Injection DOSAGE FORM/ STRENGTH: 1 mcg/mL Case-by-case funding is provided for dialysis patients. Please submit all relevant clinical data to enable an assessment by the EAP. Calcitriol Injection, USP (calcitriol) 1mcg/mL Inj Sol – 1mL Pk (imported by STE) – Effective Date: July 17, 2024 This imported US product (PIN 09858344) is funded under the EAP on a temporary basis case by case and for those stabilized with an existing EAP approval. This is to manage a product shortage of calcitriol injection 1 mcg/mL (STE) DIN 02399334 that is funded under the EAP. 247 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 247, record 148, corpus 2025-01-01; name match only, not an eligibility decision
1 brand, same coverage
Calcitriol Injection USP · DIN 02399334 Manufacturer: Sterimax Inc.; listing date 2016-06-29 Health Canada: Dormant since 2025-04-23 · brand CALCITRIOL INJECTION USP · ATC A11CC04 CALCITRIOL · form Solution · route Intravenous · ingredients CALCITRIOL 1 MCG/ML · company Sterimax inc · schedule Prescription
Check this DIN again · Health Canada product record

Calcitriol Injection USP: Formulary list price $9.5132/unit (unit not stated in source; not the patient's cost)

Ministry pays: $9.5132 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88422 · Verify on the e-Formulary ↗ (DIN 02399334)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02399334). DIN 02399334: Calcitriol Injection USP Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 881600016; group id 886; item number 2131; lccId None; manufacturer id STE Source form: Inj Sol Amp-1mL Pk; strength: 1mcg/mL Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $9.5132; ministry $9.5132 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02399334 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88422
Interchangeable products
Calcijex · DIN 00891738 · not recorded
Shortage status: active shortage (reported 2024-06-01, last updated 2026-08-26) · Tier 3; reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02399334
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Dormant since 2025-04-23 — choose a marketed DIN from the same-category list.
Other drugs in the same formulary class (88:16 Vitamin D) and how they are covered

Matched class: 88:16 Vitamin D

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Covered without a code on the Ontario formulary: ALFACALCIDOL Some products covered without a code (check the product listing): ERGOCALCIFEROL 88:16 Vitamin D

ALFACALCIDOL

· 5 products · General benefit · strengths: 0.25mcg, 1mcg, 2mcg/mL · Cap, Oral Drops

ERGOCALCIFEROL

· 2 products · Listed, not a benefit (1), General benefit (1) · strengths: 8288IU/mL · O/L Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 88:16
Full class listing Related classes: 88:08 Vitamin B, 88:12 Vitamin C, 88:28 Multivitamins Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE ROCALTROL (calcitriol capsules) is indicated in the management of:  Hypocalcemia and osteodystrophy in patients with chronic renal failure undergoing dialysis.  Hypocalcemia and its clinical manifestations associated with:  Post-surgical hypoparathyroidism.  Idiopathic hypoparathyroidism.  Pseudohypoparathyroidism.  Vitamin D resistant rickets (familial hypophosphatemia). Geriatrics (>65 years of age): Limited data are available in patients 65 years of age or older. Caution should be used when treating elderly patients. Pediatrics (<18 years of age): The safety and efficacy of calcitriol capsules in children have not been sufficiently investigated. Use is not recommended in this patient population. https://pdf.hres.ca/dpd_pm/00059786.PDF PM date: January 26, 2021 Source product: ROCALTROL; DIN 00481815; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Availability

Calcitriol Injection USP · DIN 02399334 Shortage status: active shortage (reported 2024-06-01, last updated 2026-08-26) · Tier 3; reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02399334

Check this DIN again
Health Canada: dormant products
Health Canada defines dormant products as: “products that were previously marketed in Canada but for which the manufacturer has suspended sale for period of at least 12 months.” (canada.ca, Sep 10, 2026 ↗)

Prepare an Exceptional Access request

SADIE has its own form for many drugs; this checklist prepares the answers; the ministry decides. Open SADIE

Use this text in SADIE’s free-text fields or read from it on a Telephone Request Service call. Review marks do not indicate eligibility. Evidence stays in this page until you copy it; nothing entered here is sent or saved. Do not enter patient identifiers.

EAP Telephone Request Service: The TRS can be accessed by calling toll-free at 1-866-811-9893 or 416-327-8109 (Toronto area) between 8:30 a.m. and 5:00 p.m. Monday through Friday (except holidays) and selecting the TRS option. Source; updated September 15, 2026

EAP fax: In Ontario: 1-866-811-9908 or 416-327-7526 (Toronto area). Outside Ontario: 1-833-905-4260. Source; updated September 15, 2026

Posted turnaround and Telephone Request Service scope
Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days |
For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day.
Source; updated September 15, 2026

Calcitriol (Sterimax Calcitriol Injection)

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Prepare answers: See the ministry wording below; no separate indication heading is held.

Ministry criteria corpus 2025-01-01; page 247

Calcitriol Brand(s): Sterimax Calcitriol Injection DOSAGE FORM/ STRENGTH: 1 mcg/mL
Case-by-case funding is provided for dialysis patients. Please submit all relevant clinical data to enable an assessment by the EAP.
Calcitriol Injection, USP (calcitriol) 1mcg/mL Inj Sol – 1mL Pk (imported by STE) – Effective Date: July 17, 2024
This imported US product (PIN 09858344) is funded under the EAP on a temporary basis case by case and for those stabilized with an existing EAP approval. This is to manage a product shortage of calcitriol injection 1 mcg/mL (STE) DIN 02399334 that is funded under the EAP.
247

Prepared from the ministry's published criteria; eligibility is decided by the Exceptional Access Program.

Other review policies

For Calcitriol Injection USP: no applicable EAP criteria are held and no ODB benefit is established. These policies do not establish coverage.

For rare, immediately life-, limb- or organ-threatening circumstances, the Compassionate Review Policy may consider an unfunded drug or indication, subject to its criteria and without bypassing the drug review process. Compassionate Review Policy

Compassionate Review Policy: source quote
Where there are rare clinical circumstances in immediately life, limb, or organ-threatening conditions, the Executive Officer will also consider requests for drugs or indications in situations where there has not been a decision by the Executive Officer to provide funding of the drug or indication as part of the Ontario Drug Benefit program (and the EAP), and the drug or indication requested would not circumvent the established review process for new drugs or indications as part of the drug submission process for listing within the Ontario Drug Benefit program. Requests must meet the criteria for the Compassionate Review Policy.

Ontario source; updated September 15, 2026

For cancer drugs, Case-by-Case Review considers rare, immediately life-threatening circumstances when no satisfactory funded treatment exists; its criteria and application process apply. Case-by-Case Review (cancer drugs)

Case-by-Case Review (cancer drugs): source quote
Note: Requests for cancer drugs are considered under the Case-by-Case Review Program (CBCRP) which is administered by Ontario Health (Cancer Care Ontario) on behalf of the Ministry of Health. The CBCRP considers funding requests for drugs (both oral therapies and injectable drugs) for the treatment of cancer in patients who have a rare clinical circumstance that is immediately life-threatening (death is likely within a matter of months) and who require treatment with an unfunded drug, because there is no other satisfactory and funded treatment. Please refer to the Ontario Health website for information on the application process, FAQs, eligibility criteria and program policies.

Ontario source; updated September 15, 2026